S-ROM Total Hip Replacement System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K920739 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SN

• S-ROM ZTT Acetabular Cup-Apical Hole Plug

  Class III

  FDA 510(k) K931676 Active Cleared 18 May 1994

• S-Rom Femoral Hip Stem - Size 14 X 8

  Class II

  FDA 510(k) K954935 Active Cleared 22 Jan 1996

• Knee Prothesis

  Class II

  FDA 510(k) K941769 Active Cleared 1 Feb 1995

• Src Total Knee

  Not classified

  FDA 510(k) K841022 Active Cleared 25 Jun 1984

• S-Rom Opc (One-Piece Cemented) II Femoral Hip Prosthesis

  Class II

  FDA 510(k) K951084 Active Cleared 31 May 1995

• S-Rom 135 Femoral Stem & Collar(Part of S-Rom Hip

  Class II

  FDA 510(k) K851422 Active Cleared 18 Sep 1985

See all devices from Joint Medical Products Corp. →

• What is the S-ROM Total Hip Replacement System used for?

  This device is intended to replace a portion of the hip joint in patients with hip joint damage or degeneration. It is designed to restore function and mobility.

• Is the S-ROM Total Hip Replacement System sterile?

  Yes, the device is supplied sterile and is intended for single-use only. Proper storage and handling are required to maintain sterility and functionality.

• How is the S-ROM Total Hip Replacement System supplied?

  The system is supplied as a single-use implant. It is intended for use in orthopedic procedures and is regulated under FDA 510(k) clearance.

• What is the regulatory status of the S-ROM Total Hip Replacement System?

  The device is regulated under FDA 510(k) clearance. The submission was reviewed by the Orthopedic (OR) review advisory committee.